Sun Bum Kids Face Stick Spf 50

Sun Bum Kids Face Stick Spf 50
SPL v2
SPL
SPL Set ID 90ae5bb0-d199-485e-9d36-c3db28289357
Route
TOPICAL
Published
Effective Date 2022-08-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Homosalate (100 mg) Octisalate (50 mg) Octocrylene
Inactive Ingredients
Octyldodecanol Medium-chain Triglycerides Butyloctyl Salicylate Dibutyl Ethylhexanoyl Glutamide Dibutyl Lauroyl Glutamide Adipic Acid .alpha.-tocopherol Acetate Pongamol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2022-09-01

Description

Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 10%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 10%

Uses

• helps prevent sunburn • if used as directed with other sun protection measures, (see Directions ) decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

Directions

• apply liberally 15 minutes before sun exposure

• reapply: • after 80 minutes of swimming or sweating

• immediately after towel drying • at least every 2 hours

• children under 6 months of age: ask a doctor

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

• limit time in the sun, especially from 10 a.m.- 2 p.m.

• wear long-sleeved shirts, pants, hats and sunglasses

Do Not Use

on damaged or broken skin

Drug Facts

Questions?

1-877-978-6286

Other Information

protect this product from excessive heat and direct sun

Package Labeling:

Active Ingredients

Avobenzone 3%, Homosalate 10%,

Octisalate 5%, Octocrylene 10%

Inactive Ingredients

octyldodecanol, caprylic/capric triglyceride, butyloctyl salicylate, dibutyl ethylhexanoyl glutamide, dibutyl lauroyl glutamide, trimethylentanediol/ adipic acid/glycerin crosspolymer, tocopheryl acetate, fragrance, pongamol

When Using This Product

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor

if rash occurs

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center immediately.


Structured Label Content

Uses

• helps prevent sunburn • if used as directed with other sun protection measures, (see Directions ) decreases the risk of skin cancer and early skin aging caused by the sun

Purpose

Sunscreen

Warnings

For external use only

Directions

• apply liberally 15 minutes before sun exposure

• reapply: • after 80 minutes of swimming or sweating

• immediately after towel drying • at least every 2 hours

• children under 6 months of age: ask a doctor

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

• limit time in the sun, especially from 10 a.m.- 2 p.m.

• wear long-sleeved shirts, pants, hats and sunglasses

Do Not Use (Do not use)

on damaged or broken skin

Drug Facts

Questions?

1-877-978-6286

Other Information (Other information)

protect this product from excessive heat and direct sun

Package Labeling:

Active Ingredients (Active ingredients)

Avobenzone 3%, Homosalate 10%,

Octisalate 5%, Octocrylene 10%

Inactive Ingredients (Inactive ingredients)

octyldodecanol, caprylic/capric triglyceride, butyloctyl salicylate, dibutyl ethylhexanoyl glutamide, dibutyl lauroyl glutamide, trimethylentanediol/ adipic acid/glycerin crosspolymer, tocopheryl acetate, fragrance, pongamol

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if rash occurs

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center immediately.


Advanced Ingredient Data


Raw Label Data

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